NCT01581814 is a Phase 3 clinical trial of Metformin in Polycystic Ovary Syndrome, sponsored by Catholic University of the Sacred Heart.

Who is sponsoring NCT01581814?

NCT01581814 is sponsored by Catholic University of the Sacred Heart.

What drugs are being tested in NCT01581814?

Interventions in NCT01581814: Metformin, Yasmin;, Metformin plus Yasmin.

What condition does NCT01581814 study?

NCT01581814 studies Polycystic Ovary Syndrome.

Is NCT01581814 still recruiting?

NCT01581814 is currently completed. Last updated 19 April 2012.

Last reviewed 2012-04-19 · How we verify

NCT01581814

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

Completed Phase 3 Last updated 19 April 2012

What this trial tests

Phase 3 trial testing Metformin in Polycystic Ovary Syndrome in 99 participants. Completed in 1 March 2012.

Timeline

1 October 2008

Primary endpoint
1 July 2011

1 March 2012

Quick facts

Lead sponsor	Catholic University of the Sacred Heart
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	99
Start date	1 October 2008
Primary completion	1 July 2011
Estimated completion	1 March 2012
Sites	1 location across Italy

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Yasmin;
Metformin plus Yasmin — full drug profile →

Conditions studied

Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

Catholic University of the Sacred Heart

Who can join

Adults 18 to 35, female only, with Polycystic Ovary Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

CD4+CD28null frequency
Time frame: five minutes

Sponsor's own description

To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Polycystic Ovary Syndrome

Currently open trials in the same condition.

NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting

Other Catholic University of the Sacred Heart trials

Trials by the same sponsor.

NCT07476599 — The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Ob · NA · not yet recruiting
NCT07516392 — Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma · NA · not yet recruiting
NCT07140705 — Personalized Virtual Reality for Promoting Well-Being and Psychological Flexibility in General Practitioners · NA · completed
NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
NCT06852183 — Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01581814 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Catholic University of the Sacred Heart
Last refreshed: 19 April 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01581814.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing